BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6388383 · Received March 8, 2017

    Report

    Report Number
    2031642-2017-00832
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Report Date
    February 11, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UPS, KEY MARKET (KM) REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THROUGH FOLLOW-UPS, KM INDICATED THAT THE REPORTED PROBLEM WAS CONFIRMED. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND OBSERVED THAT THE POWER SUPPLY WAS DEFECTIVE. FSE REPLACED THE POWER SUPPLY AND THE MAIN HARNESS TO ADDRESS THE REPORTED PROBLEM. THE UNIT WAS RETURNED BACK TO SERVICE. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. NO PARTS RETURNED TO FAILURE INVESTIGATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF PARTS ARE RETURNED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS AUTOMATICALLY SHUTTING DOWN. THE CUSTOMER REPORTED THAT THE UNIT WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS AUTOMATICALLY SHUTTING DOWN. THROUGH FOLLOW-UPS, KEY MARKET (KM) REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172199 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1